NCT01335139

Long-Term Effects of Sublingual Grass Therapy

A Randomized, Double-blind, Single-center, Placebo Controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults With Seasonal Allergic Rhinitis (ITN043AD)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 106 (actual)
• Sponsor: National Institute of Allergy and Infectious Diseases (NIAID) · NIH
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.

Detailed description

This is a randomized, double-blind, single-center, placebo-controlled, three-arm study comparing SLIT with placebo and SCIT with placebo. The main comparison will be between SLIT and placebo. Individuals with severe grass pollen hay fever, with or without associated seasonal asthma, will be recruited during the pollen season of March through September 2011. Eligible participants will be randomized to one of the following three treatment arms administered in a double-blind (masked), double-dummy fashion in a 1:1:1 ratio: * SLIT + SCIT placebo * SCIT + SLIT placebo * SLIT placebo + SCIT placebo Participants will receive treatment over a 2-year period followed by a 1-year blinded (masked) withdrawal phase. Participants will be provided with anti-allergic rescue medications (antihistamine, topical intranasal corticosteroids, and short-acting beta agonists) throughout the study. Clinical endpoint assessments will be performed at prior to initiating their assigned treatment, after 1 and 2 years of treatment, and after the 1-year withdrawal period at 3 years.

Conditions

• Rhinitis, Allergic, Seasonal

Interventions

Type	Name	Description
BIOLOGICAL	Sublingual immunotherapy (SLIT)	Participants randomized to receive sublingual allergen tablet immunotherapy with placebo injections.
BIOLOGICAL	Subcutaneous immunotherapy (SCIT)	Participants randomized to receive subcutaneous injection immunotherapy with placebo tablets. Subcutaneous immunotherapy was included as a positive control.
OTHER	Placebo	Participants randomized to double-placebo tablets and injections. This group was included as a negative control.

Timeline

• Start date: 2011-03-01
• Primary completion: 2015-02-01
• Completion: 2015-02-01
• First posted: 2011-04-14
• Last updated: 2017-06-02

Locations

1 site across 1 country: United Kingdom